FDA rejects InterMune’s drug for fatal lung disease

The Food and Drug Administration have announced that they have rejected the company behind a new drug that was developed to treat the fatal lung disease known as Forest lung disease. InterMune, Inc. was the company behind the drug which the FDA turned down stating that there were too many negative side effects to the proposed drug. Shares of stock in the company dropped nearly 80 percent and the rejection says that it will be years before and if the drug will be able to come to market, if ever.

Chairman, Chief Executive Officer and President of InterMune, Dan Welch has stated, “We will meet with the FDA as soon as possible to understand their points of view and to determine the most appropriate path forward to expeditiously make Esbriet available to the approximately 100,000 patients with IPF and their families who suffer from this terrible disease and for whom no FDA-approved medicines exist.”

The expierimental drug was called pirfenidione and was developed to treat idiopathic pulmonary fibrosis, a condition which causes extreme scarring due to unknown causes. The rejection of the drug sent Intermune’s stock shares to fall to $9.45 after they had closed the previous day at $45.44. A panel of medical advisors to the FDA back in March gave an approval to the drug which at the time sent the stock shares soaring nearly 60 percent. Still, CEO of Intermune, Inc. Dan Welch stated that the panel approved 9-3 back in March but the FDA but a block to it.

ThinkEquity Analyst Brian Skorney, said that it is quite negative for the organization. They will require more information from the FDA, but it appears that it will be a considerable several years setback.

Investors had been anticipating approval after a U. S. team of specialist advisors to the FDA in March voted to support the drug in spite of some stipulations regarding side effects, sending InterMune shares going up some 60% at the time.

But Tuesday’s delay sent the shares going down to $9.45 in after hours trading from their Nasdaq close at $45.44.

The biopharmaceutical company, InterMune, focuses its research and development on treatments related to the fields of pulmonology and hepatology. InterMune stock had been rising, but has fallen by around 80% since the FDA’s announcement.